Endoscopic Treatment of Biliary Strictures After LTX: Balloon Dilatation Versus Stent Placement

Biliary Stricture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487201
• Other study ID #: 120-2006
• Status: Completed
• Phase: N/A
• First received: June 13, 2007
• Last updated: June 15, 2007
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Background and Study Aims: Biliary strictures are a major cause of morbidity following liver transplantation with an overall incidence between 10 and 30 %. Up to now biliary strictures were dilated subsequently one to three plastic stents with a diameter of eight to ten F were inserted. In general, stents were exchanged in two to three months intervals over one year. In the present prospective controlled study, efficacy and complication rates of balloon dilation have been compared with dilation plus stenting.

Patients and Methods: XY patients with high-grade biliary strictures (anastomotic and non-anastomotic) were enrolled in this prospective study in random order. X patients were treated by endoscopic balloon dilatation and Y by balloon dilatation plus plastic stent placement in six to eight weeks intervals. The primary end point was permanent opening of the biliary obstruction of 12 months. Number of endoscopic interventions and complications of the procedures were monitored.

Description:

Endoscopic treatment was performed by experienced endoscopists who had each performed more than 1000 ERCP procedures. The procedure was performed with the patient under general anesthesia with propofol. A stenosis was considered to be present if the cholangiogram showed strictures with a narrowing of the anastomosis or the proximal donor duct site of the anastomosis and incomplete distal runoff of the contrast agent.

The patients were divided into two groups: 1) balloon dilatation of the stricture, 2) balloon dilatation plus plastic stent placement.

In both groups, endoscopic treatment of the patients comprised sphincterotomy, consecutive dilation of stenosis up to 10 F, removement of occluding material from choledochus duct using a balloon catheter if necessary, and repetitive balloon dilatation of the anastomosis stricture or of the non-anastomotic proximal donor duct stricture to 18 F at the first intervention and to 24 F in the following interventions.

The second group of the patients were additionally treated by large-diameter (10 F) plastic stent placement after balloon dilatation. This procedure was repeated in 6 - 8 weeks intervals in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• liver transplanted patients with diagnosis of biliary obstruction based on endoscopic cholangiopancreaticography older than 18 years male and female

Exclusion Criteria:

• patients with multiple organ transplantation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Stenosis
• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

Procedure:
• endoscopic balloon dilatation

• plastic stent placement

Locations

Country	Name	City	State
Germany	Uniklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Medizinische Universitätsklinik Ulm	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Graziadei IW, Wiesner RH, Batts KP, Marotta PJ, LaRusso NF, Porayko MK, Hay JE, Gores GJ, Charlton MR, Ludwig J, Poterucha JJ, Steers JL, Krom RA. Recurrence of primary sclerosing cholangitis following liver transplantation. Hepatology. 1999 Apr;29(4):1050-6. — View Citation

Sossenheimer M, Slivka A, Carr-Locke D. Management of extrahepatic biliary disease after orthotopic liver transplantation: review of the literature and results of a multicenter survey. Endoscopy. 1996 Sep;28(7):565-71. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permanent opening of the biliary obstruction.		12 months
Secondary	number of endoscopic interventions and complications of the procedures		12 months